BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-DEHP EXTENSION SET WITH 1.2 MICRON DOWNSTREAM AIR ELIMINATING FILTER, INTERL

    MDR report key: 5201379 · Received October 29, 2015

    Report

    Report Number
    MW5057663
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 29, 2015
    Manufacturer
    BAXTER
    Product Code
    FPB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    MOM REPORTS THAT SHE FOUND PT WITH THE COVER OF THE TPN TUBING FILTER IN HIS MOUTH. THE COVERING IS A THIN, CLEAR PLASTIC AND IS NOT PERMANENTLY ATTACHED TO THE FILTER. MOM REMOVED PLASTIC COVERING FROM PT'S MOUTH AND HE HAD NO ILL EFFECTS. EVENT REPORTED TO INFUSION MANAGER WHO INVESTIGATED THE PRODUCT FURTHER. PHS NURSE INSTRUCTED MOM TO TAPE THE PLASTIC SHIELD IN PLACE FOR NOW. THIS PRODUCT WILL BE REPLACED WITHIN THE NEXT FEW WEEKS, AS IT WAS ONLY A TEMPORARY FIX TO A TUBING SHORTAGE. INFUSION NURSE MANAGER TOOK OUT ANOTHER FILTER FROM THE TUBING SET AND THE FILTER COVER POPPED OFF VERY EASILY. THIS TUBING SET AND FILTER WAS A TEMPORARY SUPPLY AS THE TUBING AND FILTER WE TYPICALLY USE FOR TPN WAS ON BACKORDER BY THE MFR. THEY HAVE CLEARED THE BACKORDER, SO WE WILL GO BACK TO WHAT WE WERE USING BEFORE. WAREHOUSE PULLED ALL OF THE REMAINING SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720824 NON-DEHP EXTENSION SET WITH 1.2 MICRON DOWNSTREAM AIR ELIMINATING FILTER, INTERL TPN CADO TUBING AND FILTER FPB BAXTER 2C1103 R15D29053

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR